BEUDAMED
    FDA Enforcement Class II Terminated

    Amerigel Hydrogel Wound Dressing Wound management

    Recall: Z-0497-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0497-2015
    Event ID
    69394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amerx Health Care Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 10, 2014
    Initiation Date
    September 26, 2014
    Classification Date
    December 3, 2014
    Termination Date
    October 3, 2016
    Address
    1300 S. Highland Avenue, N/A, Clearwater, FL, 33756, United States

    Description

    Amerigel Hydrogel Wound Dressing Wound management

    Reason

    Formulation deviation

    Code Info

    Model # A2001, Lot #s: YWD13, YWD15, YWD16, 2WD01, 2WD02, 2WD03, 2WD04, 2WD05, 2WD08, 2WD09, 2WD11, 2WD13, 2WD14, 2WD15, 2WD17, 2WD18, 3WD01, 3WD02, 3WD03, 3WD04, 3WD05

    Distribution

    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

    Quantity

    340,896